Extended release pharmaceutical composition of clozapine

Abstract

An extended release pharmaceutical composition of Clozapine The extended release composition of Clozapine provides an extended release pharmaceutical composition having Clozapine, a seal coating, an acidic coating, and an extended release coating. The composition is particularly suitable for dispensing a once-a-day solid oral pharmaceutical formulation which releases a therapeutically effective amount of Clozapine over an extended time period.

We claim: 
     
       1. A process for preparation of an extended release pharmaceutical composition of Clozapine comprising steps of:
 1) sifting Clozapine with diluents, 
 2) preparing granules of clozapine by granulating material of step 1), 
 3) extruding the granules of step 2) using an extruder or spheronizing of step 2) using a spheronizer to prepare pellets, beads or spheroids; 
 4) seal coating on the extruded granules, pellets, beads or spheroids obtained in step 3); 
 5) providing an acidic coating on extruded granules, pellets, beads or spheroids obtained in step 4); and 
 6) providing an extended release coating on extruded granules, pellets, beads or spheroids obtained in step 5); 
 7) the extended release coated extruded granules, pellets, beads or spheroids are compressed in the form of tablets, mini-tablets or filled in capsules.